1. The 30-day composite primary safety endpoint of > 40.5% was achieved for Trilogy TAVI.

2. 8% of patients who underwent Trilogy TAVI had passed at the 1-year follow-up.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Surgery remains the primary intervention for native aortic regurgitation, but high-risk patients lack optimal alternatives. Traditional transcatheter heart valves are associated with embolization and paravalvular regurgitation. The Trilogy transcatheter heart valve, designed by JenaValve Technology, may address this need. This randomized controlled trial aimed to assess the safety and efficacy of Trilogy transcatheter aortic valve implantation (TAVI) in the management of severe aortic regurgitation. The primary outcome was the achievement of a composite safety endpoint at 30 days, while a key secondary outcome was 1-year all-cause mortality. According to study results, the Trilogy valve demonstrated satisfactory short-term safety and efficacy in treating severe aortic regurgitation. Although this study was well done, it was limited by its single-arm design and relatively short follow-up period.

Click to read the study in The Lancet

Relevant Reading: Transcatheter or Surgical Treatment of Aortic-Valve Stenosis

In-depth [randomized controlled trial]: Between Jun 8, 2018, and Aug 29, 2022, 346 patients were screened for eligibility across 20 US sites. Included were patients ≥ 18 years old with high-risk aortic regurgitation after surgical aortic valve replacement. Altogether, 180 patients were included in the final analysis, of which 177 underwent Trilogy TAVI. The mean patient age was 75.5 years (standard deviation [SD] 10.8) and the majority were White (73%) males (53%). The primary outcome of the 30-day composite safety endpoint was achieved, with a 27% (97.5% confidence interval [CI] 19.2-34.0, pnon-inferiority<0.0001) event rate. Similarly, the secondary outcome of 1-year all-cause mortality was attained with a mortality rate of 7.8% (97.5% CI 3.3-12.3). Overall, findings from this study suggest that the Trilogy transcatheter heart valve demonstrates safety and effectiveness in treating high-risk patients with native aortic regurgitation.

Image: PD

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